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FDA 510(k) Application Details - K980316
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K980316
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 FIRST ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, P.E.I. C1E1B0 CA
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Contact
KAREN CALLBECK
Other 510(k) Applications for this Contact
Regulation Number
862.1050
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Classification Product Code
CJE
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More FDA Info for this Product Code
Date Received
01/27/1998
Decision Date
02/12/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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